Kornimate/medical-research-clean huggingface dataset:
oxidative stress in obstructive sleep apnea: correlation of biomarkers and nasal cpap compliance

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to check blood and urine levels to further define markers/tests in the blood and urine that would be useful in following patients with obstructive sleep apnea and then to see if by wearing cpap every night, these markers can be reduced. this research is being done because currently there are no effective blood or urine markers to determine how well cpap is working.

the goal of this study is to further define biomarkers that would be useful in following patients with obstructive sleep apnea and examining their response to compliance to therapy with cpap. to date no correlation between biomarkers of oxidative stress and compliance to cpap has been measured. cpap is the most effective treatment for obstructive sleep apnea and has been show to reduce blood pressure and decrease oxidative stress.

Eligibility criteria:
inclusion criteria: * men and women over 18 years suspected of having sleep apnea exclusion criteria: * those under 18 years or not suspected of having sleep apnea

Keywords: obstructive sleep apnea
impact of preoperative hypocaloric hyperproteinic lipid restricting diet on bariatric surgery

Conditions: Obesity, Abdominal

Summary: obesity is one of the greatest pandemics of the 21st century with 30 million new cases each year. in france each year, 60,000 bariatric surgery procedures are performed. many preoperative diets have been proposed in the literature with some studies giving positive results. but these diets are often strict and can have adverse effects on metabolism. very few studies have described the psmf diet. the hypothesis would be that this diet is associated with a reduction in liver volume with a reduction in steatosis.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * man and woman * patient operated on at the hus between 2010 and 2021 for bariatric surgery * patient not objecting to the reuse of their data for scientific research purposes. exclusion criteria: - patient who has expressed his opposition to the reuse of his data for scientific research purposes.

Keywords: obesity, abdominal preoperative diets psmf diet
comparison of veliparib and whole brain radiation therapy (wbrt) versus placebo and wbrt in adults with brain metastases from non-small cell lung cancer

Conditions: Brain Metastases From Non-small Cell Lung Cancer

Summary: the primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * subject must have cytologically or histologically confirmed non-small cell lung cancer * subject must have brain metastases demonstrated on a magnetic resonance imaging (mri) brain scan. * subject must be eligible for treatment with wbrt * subject must have had adequate hematologic, renal, and hepatic function. exclusion criteria: * subject is diagnosed with brain metastases greater than 28 days prior to day 1 * subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases * subject's last dose of anti-cancer therapy or investigational therapy was less than or equal to 7 days prior to day 1 * subject has a karnofsky performance score of less than 70 * subject has significant dyspnea requiring supplemental oxygen therapy * subject has liver metastases (restaging is not required for known liver metastases) * subject has more than 2 sites (organ systems) of metastases from non-small cell lung cancer with the exception of intra-cranial sites of metastases from non-small cell lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone metastases * subject has leptomeningeal metastases or subarachnoid spread of tumor * subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment * subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. subjects presenting with symptoms of seizures from the brain metastases are eligible; however he/she should receive adequate anti-seizure medication prior to study treatment * subject is pregnant or lactating * subject has previously been treated with a poly-(adp-ribose)-polymerase inhibitor as an investigational agent * subject has clinically significant and uncontrolled major medical condition(s) * subject has a history of another active cancer within the past 5 years except: cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell carcinoma of the skin or other cancer in situ that is considered cured
an observational study of braf inhibitors effectiveness in patients with newly diagnosed metastatic melanoma

Conditions: Malignant Melanoma

Summary: this observational study will evaluate the effectiveness of braf inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without braf v600 mutation. patients will be treated per the locally approved therapeutic options in clinical practice. the observation period for each patient will be up to 24 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age at diagnosis * histologically confirmed new diagnosis of unresectable or metastatic melanoma * patients with tumor samples available for assessment of braf v600 mutation exclusion criteria: * prior systemic therapy for metastatic disease * participation in interventional clinical trials
comparison of initial treatment in with laser grid in diabetic macular edema to intra vitreal avastin injections

Conditions: Diabetic Macular Edema; Diabetus Mellitus

Summary: there is no yet agreement about the best way to treat diabetic macular edema (dme) the two options up to day are using grid laser treatment vs. avastin injections or a combination of both in this study we want to compare the two attitudes.


Eligibility criteria:
inclusion criteria: * diabetic patients with macular edema * age 30 to 80 yrs. old * no previous ocular treatment * patiens with macular edema that was shown by oct or fa * patients with at least 6 months follow-up after the last treatment exclusion criteria: * patients with other ocular disease (such as glaucoma etc.) * patients with previous ocular surgery * patiens with eye trauma * patiens with macular edema not from dm
evaluating the change of overactive bladder symptoms in women post pubovaginal sling procedure for stress incontinence

Conditions: Urinary Bladder, Overactive

Summary: pubovaginal sling (pvs) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. a common purported side effect of pvs is urgency, the feeling of a compelling need to void with little warning. other overactive bladder (oab) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). anecdotal evidence from our clinic however, suggests that such de novo oab symptoms are rarely induced by pvs, and may in fact be alleviated by said procedure. it is our aim to investigate this relationship in our clinic. as a prospective member of this study, you will be asked to complete five surveys. the first survey will be administered prior to your pubovaginal sling. this will be used to establish your baseline experience of oab. over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.


Eligibility criteria:
inclusion criteria. * post-pubovaginal sling patient. * complete agreement and signing of informed consent form. exclusion criteria. * currently taking antimuscarinics or α1 blockers. * patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.

Keywords: oab urinary bladder, overactive overactive bladder syndrome vesicare urgency nocturia frequency urge urinary incontinence uui pubovaginal sling pvs incontinence
safety and efficacy study of eculizumab in paroxysmal nocturnal hemoglobinuria patients

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: a study to assess the safety and efficacy of eculizumab in japanese patients with hemolytic pnh.

the objective of this study was to assess the safety and efficacy of eculizumab in japanese patients with hemolytic pnh. in addition, the pharmacokinetics (pk) and pharmacodynamics (pd) of eculizumab in japanese patients were assessed and compared to that of non-japanese patients who had participated earlier studies of eculizumab treatment in hemolytic pnh.

Eligibility criteria:
inclusion criteria: * japanese individuals at least 12 years of age * diagnosis of pnh \> 6 months * at least one transfusion in the past 2 years for anemia or anemia-related symptoms * ldh level ≥ 1.5 x upper limit of normal within 12 weeks * presence of a glycosylphosphatidylinositol (gpi)-deficient red blood cell (rbc) clone (type iii cells) by flow cytometry of ≥10% * negative serum pregnancy test for women of child-bearing potential exclusion criteria: * platelet count \< 30,000/µl * absolute neutrophil count ≤ 500/µl * known or suspected hereditary complement deficiency * history of hematopoietic stem cell transplant * history of meningococcal disease

Keywords: hemolytic paroxysmal nocturnal hemoglobinuria eculizumab pnh japan
biomarkers that predict response to high-dose aldesleukin in metastatic kidney cancer or metastatic melanoma

Conditions: Kidney Cancer; Melanoma (Skin)

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.

objectives: * determine the relationship of peripheral blood lymphocyte phenotype pattern in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose aldesleukin (il-2). * determine the relationship of peripheral blood mononuclear cells gene microarray patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose il-2. * determine the frequency of mutations on genes encoding for il-2 receptor a and b. outline: patients receive high-dose aldesleukin (il-2) as part of standard treatment on days 1 and 8. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after the completion of course 2. samples are analyzed using peripheral blood cytometry, gene microarray analysis, and il-2 receptor single-nucleotide polymorphism techniques.

Eligibility criteria:
inclusion criteria: * diagnosis of metastatic renal cell carcinoma or metastatic melanoma * must be receiving treatment with high-dose aldesleukin as part of standard therapy exclusion criteria: none

Keywords: stage iv renal cell cancer stage iv melanoma
a study on the effect of high-concentrated platelet rich plasma (prp) on osteoarthritis in the thumb base.

Conditions: Osteoarthritis Thumb

Summary: this is a randomized double-blinded randomized comparison between injection of platelet rich plasma (prp) and placebo for thumb basale osteoarthritis.

the aim of this study is to evaluate if high-concentration prp injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). the primary outcome is pain on load (numerical rating scale) after 6 months. patient-rated outcome measures, pinch grip and key pinch, range of motion of the cmc.1 joint will be assessed before treatment and at 3, 6 and months after the injection. participants and assessors will be blinded.

Eligibility criteria:
inclusion criteria: * osteoarthritis in the thumb base * radiological eaton littler class 1-3. * clinical signs of thumb base osteoarthritis )pain at palpation of the cmc-1 joint and pain during provocation/grinding test). exclusion criteria: * rheumatoid arthritis * ongoing infection in the hand or wrist * history of gout or pseudogout in the hand * inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * chronic pain syndrome / centralized pain. * intra-articular injection in the affected joint within 6 months. * eaton littler class 4 (symptomatic stt joint osteoarthritis).

Keywords: cmc-1 joint thumb basal joint prp platelet-rich plasma
an rct to compare the outcomes of patients with large rotator cuff repair that undergo repair with or without sis

Conditions: Rotator Cuff Tear

Summary: the prognosis for patients with large rotator cuff tears is poor. this recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing. to date, there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears. we propose a study to compare the rate of repair failure, quality of life, function, pain, and range of motion in 60 patients with large rotator cuff. patients will be randomized (like flipping a coin) to undergo a standard rotator cuff repair with or without augmentation with sis. patients are assessed at 6 weeks, 3, 6, 12, 18, and 24 months post-operative

objective of the full randomized trial to compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa (sis) in patients with large rotator cuff tears. objectives of the pilot study 1. to obtain a preliminary estimate of the likely success of sis. 2. to formally evaluate our ability to successfully recruit eligible patients into this study. 3. to determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair. 4. to determine a more accurate estimation of sample size for the full trial using quality of life. 5. to determine the frequency with which surgeons comply with the surgical protocol. 6. to determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol.

Eligibility criteria:
inclusion criteria: patients with large rotator cuff tears (type 1b or type 2) determined by clinical examination and diagnostic imaging. criteria described by harryman et al (1991) will guide the classification of rotator cuff tears defined and reassessed at the time of surgery (type 0 = intact cuff, type 1a = thinned cuff or partial thickness defect, type 1b= full thickness defect on one tendon, type 2 = full thickness defect of two tendons, type 3 = full thickness defect of three tendons). exclusion criteria: * previous shoulder surgery, excluding acromioplasty or diagnostic arthroscopy. * inability of the surgeon to repair the tear with remaining defect no greater than 10mm in diameter, * inability of the surgeon to repair the tear with less than 1cm of medialization, * evidence of other significant shoulder pathology including, type ii-iv slap lesion, bankart lesion, hill sachs lesion, grade iii osteoarthritis). * active joint or systemic infection, * significant muscle paralysis of the shoulder girdle, * major medical illness that would preclude undergoing surgery, * patients who are unwilling or unable to be assessed according to study protocol for one year following surgery * major psychiatric illness, developmental handicap or inability to read and understand the english language
to assess safety, tolerability and physiological effects on structure and function of axa4010 in subjects with sickle cell disease

Conditions: To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease; Anemia, Sickle Cell; Sickle Cell Anemia; Sickle Cell Disorders; Sickle Cell Disease

Summary: this is an open-label study to understand the safety and tolerability of axa4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks. the study also assesses the effects of this amino acid composition on the structure and function of the vascular system. physiological effects on structure and function will be assessed by magnetic resonance imaging (mri) to assess blood flow in the brain and kidneys and the 6-minute walk with pulse oximetry. changes in blood biomarkers of inflammation will also be assessed.


Eligibility criteria:
inclusion criteria: * willing to participate in the study and provide written informed consent * male and female adolescent (ages 12 to 17 inclusive) and adult (≥ 18 years of age) subjects with a prior medically documented diagnosis of sickle cell disease (ss or β0 thalassemia) * for cohort 2 adult subjects only, a screening cerebral blood flow/ velocity by transcranial doppler (tcd) should be \>110 cm/sec * subjects must show active hemolysis at the time of screening based on each of the following parameters: * lactate dehydrogenase (ldh) ≥ 2x above upper limits of normal (uln) of the age- and gender-appropriate ranges * indirect bilirubin \> 2x of the age- and gender-appropriate uln * absolute reticulocyte counts \> 2x of the age- and gender-appropriate uln * able to ambulate (without assistance or walkers etc.) in a 6- minute walk test exclusion criteria: * ten (10) or more vascular-occlusive crisis (voc)s that required hospital or emergency room (er) visits within the past 12 months * any clinically significant changes abnormalities on the screening 12-lead ecg * estimated glomerular filtration rate \<60ml/min/1.73m2 appropriately corrected * hemoglobin (hb) ≤6.0 g/dl at screening * subjects on chronic transfusion regimens, or who received a transfusion within the last 2 months prior to screening * experienced voc or any other sickle crises (eg acute chest syndrome, splenic sequestration, dactylitis, stroke) within the last 2 months prior to screening * current or history of significant alcohol consumption * other poorly controlled medical conditions as judged by the investigator * known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.) * unable or unwilling to adhere to contraception requirements * any contraindications to an mri scan for cohort 2 only * any other condition that, in the opinion of the investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion

Keywords: amino acid food study
influence of oxytocin on the startle reflex and on its modulation

Conditions: Psychiatric Disorders

Summary: oxytocin (oxt) is currently regarded as a crucial neuropeptide in the mediation of various human social behaviors, e.g. social affiliation, social recognition, and the modulation of anxiety, mood, and aggression. an impairment of social behavior, emotional regulation as well as increased stress reactions are characteristic of several psychiatric conditions, including schizophrenia, social anxiety and ptsd, in which there is also some evidence for oxt dysfunction. the startle reflex is a basic defensive reaction that can be modulated by emotional stimuli. the investigation of the startle reflex and of its modulation is a well-validated method to test stress reactions and emotional regulation. these processes are impaired in the same psychiatric diseases, in which oxt dysfunction was evidenced. although previous animal studies showed that the dysfunction of brain oxt systems might be implicated in startle reflex and in its modulation, no study has been performed yet in human that investigated the influence of oxt administration on the startle response and on its affective modulation. a first aim of this study is to investigate the influence of oxt on stress reactivity and emotional modulation in healthy humans. a second aim is to develop a method for the investigation of anxiety disorders. fifty male healthy participants will be tested using a randomized double-blind placebo-controlled cross-over design in two occasions; once with administration of 24 iu oxt, and once with placebo using nasal sprays while performing a computer-based experiment, in which emotional pictures and auditory startle probes are presented. we will measure the subject's subjective ratings of the pictures as well as the facial emg activation, heart rate and electrodermal activation throughout the study. this project offers a unique opportunity to study the relationship between the oxt system and basic motivational and emotional behaviors. the investigation of these mechanisms is in turn greatly worthwhile, not only for understanding of the neurochemical and physiological processes involved in emotional regulation, but also for the comprehension of the neuroendocrine and neurophysiological mechanismsunderlying anxiety disorders. in the long term, it could open the possibilities of oxt as a psychobiological therapeutics of psychiatric disorders.


Eligibility criteria:
inclusion criteria: * gender: male * age \> 18 years * good command of german * non-smoker exclusion criteria: * impaired cognitive abilities * past or current psychiatric or neurological disorder * other relevant somatic disease (including liver, kidney or heart diseases - -- allergy to preserving agents (paraben contained in nasal spray) * other medication including hormonal and herbal medication * participation in other clinical studies within one month * impaired hearing

Keywords: oxytocin psychophysiology startle anxiety emotion physiology
tunisian lung cancer study

Conditions: Pulmonary Cancer

Summary: this is a prospective, multicenter, observational, national study. eligible patients will be recruited consecutively among subjects with proven lung cancer, including any disease stage withclinical, therapeutic and evolutive discription.


Eligibility criteria:
inclusion criteria: * age more than 18 years * patients receiving health care in the departments of pulmonology, oncology, radiation oncology and thoracic surgery, whose diagnosis is confirmed histologically and/or by cytology, at least 3 months before the inclusion date * informed consent exclusion criteria: * none

Keywords: pulmonary cancer registry tunisia